Harmacy

Back to the World of Me-Too Drugs: How Anti-Sanctions Will Deal a Blow to the Mental Health of RussiansTakie Dela
May 2, 2018

The ban on the import of drugs from the United States and other “unfriendly” western countries, tabled by MPs in the Russian State Duma, will worsen the mental health of Russians. Two psychiatrists discussed the consequences facing people with mental illnesses if brand-name drugs are replaced by domestic lookalikes.

The Big Picture
In early April, State Duma Speaker Vyacheslav Volodin announced the imminent expansion of countersanctions by Russia towards the US and other western countries opposed to the Russian Federation’s foreign policies. In particular, there are plans to introduce a ban on the import of drugs from the countries on the sanctions lists, but only on those drugs for which there are domestic counterparts. However, many foreign-manufactured psychotropic drugs have domestic counterparts, and they will be banned, therefore.

Russia is not a happy country in terms of psychiatry. Every fourth Russian suffers from mental illness at some point in his or her life, and between three and six percent of the populace needs to take medications regularly.

Due to severe conditions such as epilepsy, schizophrenia, clinical depression, and bipolar disorder, hundreds of thousands of Russians lose the capacity to work and are unable to adapt to society. Many of them commit suicide. Modern drugs are effective enough to let most patients lead full lives. Their well-being depends on drugs, which they must take for many years and, sometimes, their whole lives.

The drugs in question are antidepressants, antipsychotics, tranquillizers (sedatives), and normotics (mood stabilizers). Nearly all the brand-name drugs in the field are produced in Western Europe and the US. If theban is adopted, they will vanish from Russian pharmacies, since nearly all these drugs have counterparts (i.e., generics), with the same active ingredients, that are produced in Russian and Eastern Europe.

When discussing the possbile stop list, experts named two popular antidepressants: Paxil (France) and Cymbalta (USA). Many other drugs popular in Russia, including the antipsychotics Zyprexa (Eli Lilly, UK) and Seroquel (AstraZeneca, UK/Sweden), and the antidepressant Zoloft (Pfizer, USA), could be included in the ban. What would be the consequences for millions of patients?

Increasingly Ineffective Treatment
Mental equilibrium is a delicate matter, and selecting drugs to treat psychiatric conditions can much more complicated than selecting drugs to treat somatic illnesses. The optimal outcome is for the individual not merely to stop experiencing severe symptoms like obsessive suicidal tendencies and hallucinations, but also to remain capable of working and leading a social life, rather than turning into a lifeless vegetable.

People with clinical depression, which can last for years, know well the laborious process of choosing the right drug and the right dosage that will finally let them live a normal life. The process can take weeks and months.

Matters are even more complicated with bipolar disorder. The disease’s two opposite phases require different medications, and an unsuitable drug can even worse the outcome of the illness. Schizophrenia presents such a variety of symptoms that a veritable cocktail of drugs is sometimes needed, and attending physicians have to make sure the side effects do not outweigh the benefits of treatment.

“Current guidelines for pharmacotherapy recommend prescribing the brand-name drug and not substituting a generic without good reason,” says Maria Gantman, a psychiatrist at the Mental Health Center.

Dr. Gantman prescribes her patient brand-name drugs, which have undergone high-quality trials on thousands of patients and have a proven effect. Generics also undergo trials when they are licensed, trials that prove their similarity to brand-name drugs, but the evidentiary base is filled with too many gaps, she notes.

“Generics are usually less expensive, and we start off with them if the patient cannot afford the brand-name drug. The abrupt replacement of one generic with another can produce a change in the effect. Due to the peculiarities of their ingredients, generics may be absorbed at a greater or lesser rate and generate a different concentration of the active ingredient in the blood. The people who suffer most are those forced to switch from a brand-name drug they have been taking for years and that was laboriously selected for them to a generic,” explains Dr. Gantman.

She fears the Russian authorities will approach the issue in a perfunctory manner.

“For example, there is a drug that is effective in treating schizophrenia, Rispolept. There are Russian lookalikes, sold under the generic name risperidone. But if the brand-name drug is banned, it hard to imagine what lies in store for people who survive by taking Rispolept Consta (Belgium), which does not exist in this form as a generic in Russia,” says Dr. Gantman.

“The problem is that theRussian pharmaceutical industry hopelessly lags behind the western pharmaceutical industry. There are certain types of drugs Russia just cannot produce, because it does not have the resources, the equipment or the research,” continues Anatoly Shepenyov, a psychiatrist and psychotherapist. “Say, the antidepressant Cipralex (Denmark) cannot be synthesized in Russia. Folic acid is an indispensable drug, too. In Russia, it cannot be produced in the form needed for the synthesis of serotonin, that is, in the form needed for maintaining normal brain function.”

Side Effects
The side effects of psychotropic drugs are numerous and varied. Mental impairment, convulsions, fainting, anemia, and fever are only some of them. Predicting them ahead of them is impossible: they are the individual body’s reactions. A drug that simultaneously provides relief while not producing agonizing side effects is a valuable find for many patients.

Dr. Shepenyov illustrates the circumstances by mentioning the antidepressant Paxil (France). It has generics, for example, Rexetin (Hungary). Rexetin works, but its therapeutic effectiveness is lower. To get the same effect she would get from 20 mg of Paxil, thae patient would need to take at least 30 mg of Rexetin. As dosages increase, so do the side effects.

“The main difficult is not synthesizing the right substance, but isolating it in pure form. I’ll give you an example. The antidepressant must fit the receptor in the brain the way a key fits a lock. When generics are synthesized, a whole slew of impurities emerge, extra ‘keys,’ if you like. If you use this ‘dirty’ molecule, you won’t open the lock, but there will be something jammed in it,” notes Dr. Shepenyov.

The use of generics thus introduces the risk there will be a lack of therapeutic effect coupled with a slew of side effects that would never be produced by brand-name drugs. The liver also suffers more from the constant intake of “dirty” drugs.

“Take the most popular Russian-made antidepressant, Fluoxetine (a generic version of the US-produced Prozac). It is terrible in terms of side effects. Although its benefits are weak, patients suffer from phenomenal absentmindedness,” explains Dr. Shepenyov.

Withdrawal Syndrome
If western-produced drugs one day vanish from Russian pharmacies, thousands of patients will undergo withdrawal syndrome, the body’s physiological reaction to the absence of a substance to which it is accustomed.

“I felt terribly sick within a few days. I had a terrible chill, severe dizziness, nausea, weakness, and insomnia,” a female patient described her withdrawal from Paxil.

It is necessary to gradually reduce the dosage to avoid this effect, which means having a good supply of the drug and then just as gradually increasing the dosage of the new drug. This means weeks of enduring shaky health.

The Anti-Placebo Effect
“The anti-placebo effect is no less frequent and severe than the placebo effect. The patient knows she has taken another drug. This exacerbates her anxiety and could ultimately destabilize her condition. So, if an individual has taken the same drug for years and feels fine, there is no need to give her another drug. It’s risky,” says Dr. Gantman.

Both doctors are agreed that patient health should not be a geopolitical bargaining chip. According to Dr. Gantman, medical issues should be left out of the political games countries play, and she calls the State Duma’s plans to ban the imports of foreign-made drugs “profoundly unethical.”

“If Russian MPs adopt such a law, we should oblige them to be treated solely with Russian-made drugs, drive Russian-made cars, and use Russian-made telephones and computers. Those would be excellent sanctions that would finally force them to use their brains before making radical decisions without having the foggiest notion about either medicine or how the body functions,” concludes Dr. Shepenyov.

A group picket was held on Saturday, May 12, 2018, in Petersburg’s Ovsyannikov Garden, to protest the Russian State Duma’s tabling of a bill that would ban the purchase of drugs abroad. Yes, we have heard that legislators have suggested removing the word “drugs” from the wording, but we know much freighted the phrase “and other goods” can be.

To increase the chances city authorities would authorize the picket, activists applied for several venues at once. The authorities waited until the last possible moment to render a decision, and so there was no time to inform the public about the planned protest. Around a dozen people were in attendance, including a diabetic who depends on imported insulin, and several people outraged by the politics and statements of our MPs.

One of the placards featured a toy pyramid for little children, which MP Iosif Kobzon gave to a teenaged cancer patient while visiting a hospital in Simferopol in 2015. In our view, the incident reflects the lack of understanding displayed by our bigwigs when it comes to the needs of patients.

There were few visitors in the garden, and nearly none of them had heard of the law bill, but no one, from schoolgirls to a seventy-year-old female pensioner, was left unmoved by the subject. They reacted with surprise, indignation, and complete support for the picketers.

“Insulin addict. Bring it on! Deprive us of our doses, assholes. ‘Life in Russia is no picnic: you can survive without insulin.’ Insulin or formaldehyde? Neuroleptics or belladonna? You choose, Russia!”